Chronic Poststernotomy PainNCT07882836
Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG
A study testing Pecto-Intercostal Fascial Plane Block and Standardized Multimodal Systemic Analgesia in people with Chronic Poststernotomy Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This single-center, prospective, parallel-group randomized controlled trial will evaluate whether adding ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) to standard multimodal systemic analgesia reduces the incidence of clinically significant chronic poststernotomy pain in adults… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Poststernotomy Pain
- What is being tested?
- Pecto-Intercostal Fascial Plane Block and Standardized Multimodal Systemic Analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2027to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older and younger than 80 years.
- Scheduled to undergo elective isolated coronary artery bypass grafting (CABG) for coronary artery disease.
- Planned surgery through full median sternotomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status II-IV and clinically stable for elective surgery.
- Both standard multimodal systemic analgesia alone and standard multimodal systemic analgesia combined with ultrasound-guided bilateral pecto-intercostal fascial plane block (PIFB) considered clinically acceptable, with no clinical condition requiring or precluding assignment to either study approach.
- No contraindication to ultrasound-guided bilateral PIFB.
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- Able to understand the study procedures, randomization process, potential benefits and foreseeable risks and to provide written informed consent.
- Able to understand the 0-10 Numeric Rating Scale (NRS) and reliably communicate the presence, intensity, and characteristics of pain.
- Able to participate in postoperative assessments during hospitalization and in postoperative day 30 and postoperative day 90 follow-up assessments.
Who cannot join
- Age younger than 18 years or 80 years or older.
- Emergency or non-deferrable CABG surgery, preoperative hemodynamic instability, ongoing cardiogenic shock, or requirement for emergency mechanical circulatory support.
- Planned surgical approach other than full median sternotomy, including mini-sternotomy, thoracotomy, or another approach.
- Planned concomitant major cardiac surgery other than isolated CABG, including valve, aortic, congenital, or other major cardiac surgery.
- Previous median sternotomy or planned redo cardiac surgery.
- Active infection, open wound, burn, significant anatomical deformity, or other local pathology in the parasternal region that would prevent safe ultrasound-guided PIFB.
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- Known severe allergy or hypersensitivity to local anesthetics or to any medication included in the standardized multimodal analgesia protocol.
- Active clinical bleeding, disseminated intravascular coagulation, or clinically significant uncorrected coagulopathy.
- Anticoagulant or antithrombotic treatment, timing of treatment, individual bleeding risk, or block-site considerations that make PIFB inappropriate according to current regional anesthesia safety principles or institutional protocol.
- Pre-existing chronic pain lasting longer than 3 months or known neuropathic pain involving the sternum, parasternal region, anticipated chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection.
- Daily or near-daily opioid use for at least 3 months, opioid use disorder, or chronic high-dose opioid therapy.
- Dementia, delirium, severe cognitive impairment, uncontrolled severe psychiatric illness, communication impairment, or language insufficiency preventing informed consent or reliable pain assessment.
- Severe hepatic or renal dysfunction that prevents safe administration of the standardized multimodal analgesia protocol or the planned local anesthetic dose.
- Pregnancy or breastfeeding.
- Concurrent participation in another interventional clinical study that could affect postoperative pain, opioid consumption, or chronic postsurgical pain outcomes.
- Any other clinical condition considered by the investigator to make randomization to either study group unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Katip Celebi University Atatürk Training and Research Hospital
Izmir, İzmir, 35360
Murat Aksun, M.D., +90 552 363 16 14, murataksun@yahoo.com
Ahmet Salih Tüzen, M.D., +90 535 391 55 77, astuzen@icloud.com
About this study
Official title: Effect of Bilateral Pecto-Intercostal Fascial Plane Block on Chronic Poststernotomy Pain in Adults Undergoing Elective Isolated Coronary Artery Bypass Grafting Through Median Sternotomy: A Single-Blind Randomized Controlled Trial
This single-center, prospective, parallel-group randomized controlled trial will evaluate whether adding ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) to standard multimodal systemic analgesia reduces the incidence of clinically significant chronic poststernotomy pain in adults undergoing elective isolated coronary artery bypass grafting (CABG) through median sternotomy.
A total of 180 eligible participants will be randomized in a 1:1 ratio to either standard general anesthesia with standardized multimodal systemic analgesia alone or the same perioperative analgesic regimen with the addition of bilateral PIFB performed after induction of general anesthesia and before surgical incision. In the PIFB group, 15 mL of 0.25% bupivacaine will be administered on each side under ultrasound guidance. Perioperative anesthesia, systemic analgesia, rescue analgesia, intensive care management, and routine postoperative care will otherwise be standardized between groups.
Read more
The primary outcome will be the proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90. This outcome will be defined as pain that develops or worsens after surgery, is localized to the sternotomy line or related thoracic surgical areas, persists or recurs at 3 months, has an average intensity of at least 3 on a 0-10 Numeric Rating Scale during the preceding 7 days, and is not better explained by another clinical condition.
Secondary outcomes will include early postoperative pain intensity, acute pain burden, opioid consumption, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, time to extubation, duration of mechanical ventilation, intensive care unit and hospital length of stay, and persistent postoperative pain at day 30. Participants will be followed through postoperative day 90.
Read the detailed description
This single-center, prospective, parallel-group, randomized controlled trial will evaluate whether ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB), when added to standard multimodal systemic analgesia, reduces the incidence of clinically significant chronic poststernotomy pain in adults undergoing elective isolated coronary artery bypass grafting (CABG) through full median sternotomy.
A total of 180 eligible participants will be randomized in a 1:1 ratio to one of two groups. The control group will receive standard general anesthesia and standardized multimodal systemic analgesia. The intervention group will receive the same standard anesthesia and systemic analgesia protocol with the addition of ultrasound-guided bilateral single-shot PIFB after induction of general anesthesia and endotracheal intubation and before surgical incision. Randomization will be performed using a computer-generated sequence with concealed variable block sizes. Allocation concealment will be maintained until eligibility has been confirmed and written informed consent has been obtained.
The study will use blinded outcome assessment. The anesthesiologist performing the block and the operating room team cannot be blinded because of the nature of the intervention. However, investigators performing postoperative pain assessments and postoperative day 30 and day 90 follow-up evaluations will remain unaware of group allocation. No sham block or placebo injection will be used; therefore, the study will not be described as double-blind or placebo-controlled.
In participants assigned to the PIFB group, the block will be performed under ultrasound guidance by experienced anesthesiologists using a standardized technique. After identification of the target fascial plane between the pectoralis major muscle and the intercostal muscle layer and confirmation of needle position, 15 mL of 0.25% bupivacaine will be administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg. The total dose will not exceed 2 mg/kg. Ultrasound visualization of local anesthetic spread within the target fascial plane will be confirmed.
Apart from administration of PIFB in the intervention group, perioperative management will be standardized between groups. General anesthesia, intraoperative monitoring, systemic analgesia, rescue analgesia, postoperative intensive care management, and routine postoperative care will follow the same institutional protocols in both groups. Rescue analgesia will not be withheld or delayed for study purposes.
Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain will be assessed separately at rest, during coughing or deep breathing, and during mobilization when clinically feasible. Planned early postoperative assessments will be performed at 6, 12, 24, 48, and 72 hours after surgery and on postoperative day 5, or on the day of discharge if discharge occurs earlier. If a participant is intubated, sedated, delirious, or otherwise unable to communicate reliably at a scheduled assessment time, the pain assessment will not be performed and the reason will be documented.
The primary outcome will be the proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90. Clinically significant chronic poststernotomy pain will be defined as pain that develops after surgery or is aggravated by surgery; is localized to the sternotomy line, parasternal region, chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection; persists or recurs at 3 months after surgery; has an average intensity of at least 3 on the 0-10 NRS during the preceding 7 days; and is not better explained by sternal wound infection, mediastinitis, sternal instability or nonunion, recurrent myocardial ischemia, malignancy, or another clinical condition. The primary outcome will be assessed by a blinded outcome assessor using a structured interview.
Secondary outcomes will include postoperative pain intensity at rest and with coughing, deep breathing, and mobilization; acute postoperative pain burden; intraoperative and postoperative opioid consumption; rescue analgesic requirement and number of rescue analgesic administrations; time to first rescue analgesia; postoperative nausea and vomiting; oversedation; respiratory depression and other opioid-related adverse effects; time to extubation; duration of invasive mechanical ventilation; intensive care unit length of stay; hospital length of stay; and persistent postoperative pain on postoperative day 30.
All opioids administered intraoperatively and postoperatively will be recorded by drug, dose, route, and time of administration and converted to morphine milligram equivalents. Postoperative opioid consumption will be evaluated over prespecified periods including 0-24, 0-48, and 0-120 hours.
At postoperative day 30, participants will undergo structured assessment for persistent surgery-related thoracic wall pain, including pain location, average and worst pain intensity during the preceding 7 days, relationship to rest and activity, ongoing analgesic use, sleep disturbance, functional limitation, and return to usual activities or work.
At postoperative day 90, participants will undergo the primary chronic poststernotomy pain assessment. Additional assessments will include presence of any chronic poststernotomy pain, pain intensity and localization, continuous or intermittent pain pattern, ongoing analgesic use, effects on sleep and daily activities, and neuropathic pain features. In participants reporting pain, neuropathic characteristics will be assessed using the DN4 and S-LANSS instruments specified in the protocol.
Participants will be followed from the preoperative assessment through postoperative day 90. The primary analysis will follow the intention-to-treat principle, with participants analyzed according to their original randomized group regardless of treatment crossover, incomplete block performance, protocol deviations, or other post-randomization events. A per-protocol analysis will be performed as a supportive sensitivity analysis.
- Conditions
- Chronic Poststernotomy Pain
- Being tested
- Pecto-Intercostal Fascial Plane Block, Standardized Multimodal Systemic Analgesia
- Keywords
- Pecto-Intercostal Fascial Plane Block, Chronic Poststernotomy Pain, Chronic Postsurgical Pain, Coronary Artery Bypass Grafting, Median Sternotomy, Regional Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecto-Intercostal Fascial Plane BlockProcedure or surgery
Ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) will be performed after induction of general anesthesia and endotracheal intubation and before surgical incision. The target fascial plane between the pectoralis major muscle and the intercostal muscle layer will be identified under ultrasound guidance. After confirmation of needle position and negative aspiration, 15 mL of 0.25% bupivacaine will be administered on each side, for a total volume of 30 mL and a total dose of 75 mg. The total bupivacaine dose will not exceed 2 mg/kg. Ultrasound visualization of local anesthetic spread within the target fascial plane will be confirmed.
Standardized Multimodal Systemic AnalgesiaOther
All participants will receive the same standardized multimodal systemic analgesia protocol. Postoperatively, paracetamol 1 g intravenously every 6 hours will be administered during the first 24 hours, followed by paracetamol 1 g orally every 8 hours after oral intake is established. Tramadol hydrochloride 100 mg intravenously every 12 hours will also be administered unless clinically contraindicated. Nonsteroidal anti-inflammatory drugs are not mandatory components of the protocol and may be used only when clinically appropriate. If the Numeric Rating Scale pain score is 4 or higher at rest or with coughing or movement, intravenous morphine 2 mg will be administered as rescue analgesia, with further analgesic treatment provided according to clinical need.
| Study group | Role | What they receive |
|---|---|---|
| Standard Multimodal Systemic Analgesia | Active comparator | Participants assigned to the control group will receive standard general anesthesia and the standardized multimodal systemic analgesia protocol used for elective coronary artery bypass grafting at the study center. No regional analgesia procedure, sham block, or placebo injection will be performed. Rescue analgesia will be provided according to the prespecified study protocol when clinically indicated. Receives: Other: Standardized Multimodal Systemic Analgesia |
| Standard Multimodal Systemic Analgesia + Bilateral PIFB | Experimental | Participants assigned to the intervention group will receive the same standard general anesthesia and standardized multimodal systemic analgesia protocol as the control group, with the addition of ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) after induction of general anesthesia and endotracheal intubation and before surgical incision. A total of 15 mL of 0.25% bupivacaine will be administered on each side under ultrasound guidance. Receives: Procedure: Pecto-Intercostal Fascial Plane Block; Other: Standardized Multimodal Systemic Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Significant Chronic Poststernotomy Pain
The proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90 will be assessed. Clinically significant chronic poststernotomy pain will be defined as pain that develops after surgery or is aggravated by surgery; is localized to the sternotomy line, parasternal region, chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection; persists or recurs at 3 months after surgery; and has an average intensity of at least 3 on the 0-10 Numeric Rating Scale (NRS) during the preceding 7 days. Pain better explained by sternal wound infection, mediastinitis, sternal instability or nonunion, recurrent myocardial ischemia, malignancy, or another clinical condition will not be classified as chronic poststernotomy pain. The outcome will be assessed by an outcome assessor blinded to treatment allocation. Higher incidence indicates a less favorable outcome.
Measured: Postoperative Day 90
Secondary outcomes (31)
Postoperative Pain Intensity at Rest
Pain intensity at rest will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Postoperative Pain Intensity During Coughing or Deep Breathing
Pain intensity during coughing or deep breathing will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Postoperative Pain Intensity During Mobilization
Pain intensity during mobilization will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Mobilization pain will be assessed only when mobilization is clinically feasible.
Measured: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Intraoperative Opioid Consumption
Total opioid consumption administered during surgery will be recorded and converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption.
Measured: Intraoperative period
Requirement for Rescue Analgesia
The proportion of participants requiring at least one rescue analgesic intervention will be recorded. The protocol-defined primary criterion for rescue analgesia is a score of 4 or higher on the 0-10 Numeric Rating Scale (NRS) at rest or during coughing or movement; rescue analgesia may also be administered according to clinical need irrespective of the NRS threshold.
Measured: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Number of Rescue Analgesic Administrations
The total number of rescue analgesic administrations received by each participant during the assessment period will be recorded. Higher values indicate greater rescue analgesic requirements.
Measured: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Time to First Rescue Analgesia
Time from the end of surgery to the first administration of rescue analgesia will be recorded in hours. Participants who do not require rescue analgesia during the observation period will be recorded as having no rescue analgesic event during that period.
Measured: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Incidence of Postoperative Nausea
The proportion of participants experiencing at least one episode of postoperative nausea during the assessment period will be recorded.
Measured: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Incidence of Postoperative Oversedation
The proportion of participants experiencing at least one episode of clinically significant oversedation during the assessment period will be recorded. Oversedation will be defined as inability to be easily awakened, requirement for repeated stimulation, or sedation sufficiently severe to cause clinically significant impairment of communication.
Measured: From the end of surgery through 5 days after surgery or hospital discharge, whichever occurs first
Incidence of Respiratory Depression
The proportion of participants experiencing at least one episode of respiratory depression during the assessment period will be recorded. Respiratory depression will be defined as a respiratory rate below 8 breaths per minute, clinically significant inadequate ventilation, or opioid-associated impairment of oxygenation.
Measured: From the end of surgery through 5 days after surgery or hospital discharge, whichever occurs first
Time to Tracheal Extubation
Time from the end of surgery to first tracheal extubation will be recorded in hours. Participants who do not undergo tracheal extubation during the observation period will be recorded as not having achieved the extubation event. Extubation decisions will be made by the responsible clinical team according to routine institutional criteria and will not be accelerated or delayed for study purposes.
Measured: Up to postoperative day 90
Duration of Invasive Mechanical Ventilation
Total duration of postoperative invasive mechanical ventilation will be recorded in hours, from the end of surgery until final liberation from invasive mechanical ventilation. Higher values indicate a longer duration of invasive mechanical ventilation.
Measured: Up to postoperative day 90
Intensive Care Unit Length of Stay
Length of stay in the intensive care unit (ICU) will be recorded in days, from admission to the ICU after surgery until final discharge from the ICU. Higher values indicate a longer ICU stay.
Measured: Up to postoperative day 90
Hospital Length of Stay
Total hospital length of stay will be recorded in days, from the date of admission for surgery until final discharge from the index hospitalization. Higher values indicate a longer hospital stay.
Measured: Up to postoperative day 90
Incidence of Persistent Postoperative Pain
The proportion of participants reporting persistent surgery-related pain involving the sternotomy or associated thoracic surgical areas on postoperative day 30 will be recorded.
Measured: Postoperative Day 30
Presence of Any Chronic Poststernotomy Pain
The proportion of participants reporting pain that persists or recurs at 3 months after surgery and is considered related to the sternotomy or associated thoracic surgical areas will be recorded, regardless of pain intensity.
Measured: Postoperative Day 90
Average Chronic Poststernotomy Pain Intensity
Among participants reporting chronic poststernotomy pain, a single recalled rating of average pain intensity during the preceding 7 days will be obtained on postoperative day 90 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Postoperative Day 90
Worst Chronic Poststernotomy Pain Intensity
Among participants reporting chronic poststernotomy pain, a single recalled rating of the worst pain intensity experienced during the preceding 7 days will be obtained on postoperative day 90 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Postoperative Day 90
Neuropathic Pain Features Assessed With the Douleur Neuropathique en 4 Questions (DN4)
Among participants reporting pain at postoperative day 90, neuropathic pain features will be assessed using the Douleur Neuropathique en 4 Questions (DN4). The DN4 consists of 10 dichotomously scored items, with a total score ranging from 0 to 10. Higher scores indicate a greater likelihood that the pain has a neuropathic component. A score of 4 or higher will be considered indicative of neuropathic pain characteristics.
Measured: Postoperative Day 90
Neuropathic Pain Features Assessed With the Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Among participants reporting pain at postoperative day 90, neuropathic pain features will be assessed using the Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS). The S-LANSS consists of 7 weighted items, with a total score ranging from 0 to 24. Higher scores indicate a greater likelihood that the pain has a neuropathic component. A score of 12 or higher will be considered indicative of pain with neuropathic characteristics.
Measured: Postoperative Day 90
Cumulative Postoperative Opioid Consumption Through 24 Hours
Total opioid consumption during the first 24 postoperative hours will be converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption.
Measured: From the end of surgery through 24 hours after surgery
Cumulative Postoperative Opioid Consumption Through 48 Hours
Cumulative opioid consumption during the first 48 postoperative hours will be converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption.
Measured: From the end of surgery through 48 hours after surgery
Cumulative Postoperative Opioid Consumption Through 120 Hours
Cumulative opioid consumption through 120 postoperative hours will be converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption.
Measured: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Incidence of Postoperative Vomiting
The proportion of participants experiencing at least one episode of postoperative vomiting during the assessment period will be recorded.
Measured: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Average Persistent Postoperative Pain Intensity
Among participants reporting persistent postoperative pain, a single recalled rating of average pain intensity during the preceding 7 days will be obtained on postoperative day 30 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Postoperative Day 30
Worst Persistent Postoperative Pain Intensity
Among participants reporting persistent postoperative pain, a single recalled rating of the worst pain intensity experienced during the preceding 7 days will be obtained on postoperative day 30 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Postoperative Day 30
Ongoing Analgesic Use for Persistent Postoperative Pain
The proportion of participants with persistent postoperative pain who report ongoing use of analgesic medication for surgery-related pain at postoperative day 30 will be recorded.
Measured: Postoperative Day 30
Ongoing Analgesic Use for Chronic Poststernotomy Pain
The proportion of participants with chronic poststernotomy pain who report ongoing use of analgesic medication for surgery-related pain at postoperative day 90 will be recorded.
Measured: Postoperative Day 90
Pain-Related Sleep DisturbanceDescription:
The proportion of participants with chronic poststernotomy pain who report sleep disturbance attributable to surgery-related pain at postoperative day 90 will be recorded.
Measured: Postoperative Day 90
Pain-Related Physical Activity Limitation
The proportion of participants with chronic poststernotomy pain who report limitation of physical activity attributable to surgery-related pain at postoperative day 90 will be recorded.
Measured: Postoperative Day 90
Pain-Related Impairment of Activities of Daily Living
The proportion of participants with chronic poststernotomy pain who report impairment of activities of daily living attributable to surgery-related pain at postoperative day 90 will be recorded.
Measured: Postoperative Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Poststernotomy PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The control group will receive standard general anesthesia and standardized multimodal systemic analgesia. The intervention group will receive the same standard anesthesia and systemic analgesia protocol with the addition of ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) after induction of general anesthesia and before surgical incision. Perioperative management other than administration of PIFB will be standardized between the groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Salih Tüzen, MD, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882836
- Sponsor's protocol ID
- 2026-KAEK-23
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data collected in this study will not be made available to researchers outside the primary study team. No external individual participant data sharing is planned because the study protocol and informed consent do not include a prospective data-sharing arrangement.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Pecto-Intercostal Fascial Plane Block on Chronic Poststernotomy Pain in Adults Undergoing Elective Isolated Coronary Artery Bypass Grafting Through Median Sternotomy: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07882836
- Acronym / sponsor ID
- 2026-KAEK-23
- Conditions
- Chronic Poststernotomy Pain
- Keywords
- Pecto-Intercostal Fascial Plane Block, Chronic Poststernotomy Pain, Chronic Postsurgical Pain, Coronary Artery Bypass Grafting, Median Sternotomy, Regional Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, prospective, parallel-group randomized controlled trial will evaluate whether adding ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) to standard multimodal systemic analgesia reduces the incidence of clinically significant chronic poststernotomy pain in adults undergoing elective isolated coronary artery bypass grafting (CABG) through median sternotomy.
A total of 180 eligible participants will be randomized in a 1:1 ratio to either standard general anesthesia with standardized multimodal systemic analgesia alone or the same perioperative analgesic regimen with the addition of bilateral PIFB performed after induction of general anesthesia and before surgical incision. In the PIFB group, 15 mL of 0.25% bupivacaine will be administered on each side under ultrasound guidance. Perioperative anesthesia, systemic analgesia, rescue analgesia, intensive care management, and routine postoperative care will otherwise be standardized between groups.
The primary outcome will be the proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90. This outcome will be defined as pain that develops or worsens after surgery, is localized to the sternotomy line or related thoracic surgical areas, persists or recurs at 3 months, has an average intensity of at least 3 on a 0-10 Numeric Rating Scale during the preceding 7 days, and is not better explained by another clinical condition.
Secondary outcomes will include early postoperative pain intensity, acute pain burden, opioid consumption, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, time to extubation, duration of mechanical ventilation, intensive care unit and hospital length of stay, and persistent postoperative pain at day 30. Participants will be followed through postoperative day 90.
Detailed description
This single-center, prospective, parallel-group, randomized controlled trial will evaluate whether ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB), when added to standard multimodal systemic analgesia, reduces the incidence of clinically significant chronic poststernotomy pain in adults undergoing elective isolated coronary artery bypass grafting (CABG) through full median sternotomy.
A total of 180 eligible participants will be randomized in a 1:1 ratio to one of two groups. The control group will receive standard general anesthesia and standardized multimodal systemic analgesia. The intervention group will receive the same standard anesthesia and systemic analgesia protocol with the addition of ultrasound-guided bilateral single-shot PIFB after induction of general anesthesia and endotracheal intubation and before surgical incision. Randomization will be performed using a computer-generated sequence with concealed variable block sizes. Allocation concealment will be maintained until eligibility has been confirmed and written informed consent has been obtained.
The study will use blinded outcome assessment. The anesthesiologist performing the block and the operating room team cannot be blinded because of the nature of the intervention. However, investigators performing postoperative pain assessments and postoperative day 30 and day 90 follow-up evaluations will remain unaware of group allocation. No sham block or placebo injection will be used; therefore, the study will not be described as double-blind or placebo-controlled.
In participants assigned to the PIFB group, the block will be performed under ultrasound guidance by experienced anesthesiologists using a standardized technique. After identification of the target fascial plane between the pectoralis major muscle and the intercostal muscle layer and confirmation of needle position, 15 mL of 0.25% bupivacaine will be administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg. The total dose will not exceed 2 mg/kg. Ultrasound visualization of local anesthetic spread within the target fascial plane will be confirmed.
Apart from administration of PIFB in the intervention group, perioperative management will be standardized between groups. General anesthesia, intraoperative monitoring, systemic analgesia, rescue analgesia, postoperative intensive care management, and routine postoperative care will follow the same institutional protocols in both groups. Rescue analgesia will not be withheld or delayed for study purposes.
Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain will be assessed separately at rest, during coughing or deep breathing, and during mobilization when clinically feasible. Planned early postoperative assessments will be performed at 6, 12, 24, 48, and 72 hours after surgery and on postoperative day 5, or on the day of discharge if discharge occurs earlier. If a participant is intubated, sedated, delirious, or otherwise unable to communicate reliably at a scheduled assessment time, the pain assessment will not be performed and the reason will be documented.
The primary outcome will be the proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90. Clinically significant chronic poststernotomy pain will be defined as pain that develops after surgery or is aggravated by surgery; is localized to the sternotomy line, parasternal region, chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection; persists or recurs at 3 months after surgery; has an average intensity of at least 3 on the 0-10 NRS during the preceding 7 days; and is not better explained by sternal wound infection, mediastinitis, sternal instability or nonunion, recurrent myocardial ischemia, malignancy, or another clinical condition. The primary outcome will be assessed by a blinded outcome assessor using a structured interview.
Secondary outcomes will include postoperative pain intensity at rest and with coughing, deep breathing, and mobilization; acute postoperative pain burden; intraoperative and postoperative opioid consumption; rescue analgesic requirement and number of rescue analgesic administrations; time to first rescue analgesia; postoperative nausea and vomiting; oversedation; respiratory depression and other opioid-related adverse effects; time to extubation; duration of invasive mechanical ventilation; intensive care unit length of stay; hospital length of stay; and persistent postoperative pain on postoperative day 30.
All opioids administered intraoperatively and postoperatively will be recorded by drug, dose, route, and time of administration and converted to morphine milligram equivalents. Postoperative opioid consumption will be evaluated over prespecified periods including 0-24, 0-48, and 0-120 hours.
At postoperative day 30, participants will undergo structured assessment for persistent surgery-related thoracic wall pain, including pain location, average and worst pain intensity during the preceding 7 days, relationship to rest and activity, ongoing analgesic use, sleep disturbance, functional limitation, and return to usual activities or work.
At postoperative day 90, participants will undergo the primary chronic poststernotomy pain assessment. Additional assessments will include presence of any chronic poststernotomy pain, pain intensity and localization, continuous or intermittent pain pattern, ongoing analgesic use, effects on sleep and daily activities, and neuropathic pain features. In participants reporting pain, neuropathic characteristics will be assessed using the DN4 and S-LANSS instruments specified in the protocol.
Participants will be followed from the preoperative assessment through postoperative day 90. The primary analysis will follow the intention-to-treat principle, with participants analyzed according to their original randomized group regardless of treatment crossover, incomplete block performance, protocol deviations, or other post-randomization events. A per-protocol analysis will be performed as a supportive sensitivity analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The control group will receive standard general anesthesia and standardized multimodal systemic analgesia. The intervention group will receive the same standard anesthesia and systemic analgesia protocol with the addition of ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) after induction of general anesthesia and before surgical incision. Perioperative management other than administration of PIFB will be standardized between the groups.
| Arm | Type | Receives |
|---|---|---|
| Standard Multimodal Systemic Analgesia | Active comparator | Other: Standardized Multimodal Systemic AnalgesiaParticipants assigned to the control group will receive standard general anesthesia and the standardized multimodal systemic analgesia protocol used for elective coronary artery bypass grafting at the study center. No regional analgesia procedure, sham block, or placebo injection will be performed. Rescue analgesia will be provided according to the prespecified study protocol when clinically indicated. |
| Standard Multimodal Systemic Analgesia + Bilateral PIFB | Experimental | Procedure: Pecto-Intercostal Fascial Plane Block, Other: Standardized Multimodal Systemic AnalgesiaParticipants assigned to the intervention group will receive the same standard general anesthesia and standardized multimodal systemic analgesia protocol as the control group, with the addition of ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) after induction of general anesthesia and endotracheal intubation and before surgical incision. A total of 15 mL of 0.25% bupivacaine will be administered on each side under ultrasound guidance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older and younger than 80 years.
- Scheduled to undergo elective isolated coronary artery bypass grafting (CABG) for coronary artery disease.
- Planned surgery through full median sternotomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status II-IV and clinically stable for elective surgery.
- Both standard multimodal systemic analgesia alone and standard multimodal systemic analgesia combined with ultrasound-guided bilateral pecto-intercostal fascial plane block (PIFB) considered clinically acceptable, with no clinical condition requiring or precluding assignment to either study approach.
Key exclusion criteria (16 listed)
- Age younger than 18 years or 80 years or older.
- Emergency or non-deferrable CABG surgery, preoperative hemodynamic instability, ongoing cardiogenic shock, or requirement for emergency mechanical circulatory support.
- Planned surgical approach other than full median sternotomy, including mini-sternotomy, thoracotomy, or another approach.
- Planned concomitant major cardiac surgery other than isolated CABG, including valve, aortic, congenital, or other major cardiac surgery.
- Previous median sternotomy or planned redo cardiac surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pecto-Intercostal Fascial Plane BlockUltrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) will be performed after induction of general anesthesia and endotracheal intubation and before surgical incision. The target fascial plane between the pectoralis major muscle and the intercostal muscle layer will be identified under ultrasound guidance. After confirmation of needle position and negative aspiration, 15 mL of 0.25% bupivacaine will be administered on each side, for a total volume of 30 mL and a total dose of 75 mg. The total bupivacaine dose will not exceed 2 mg/kg. Ultrasound visualization of local anesthetic spread within the target fascial plane will be confirmed. | Procedure or surgery | Standard Multimodal Systemic Analgesia + Bilateral PIFB |
| Standardized Multimodal Systemic AnalgesiaAll participants will receive the same standardized multimodal systemic analgesia protocol. Postoperatively, paracetamol 1 g intravenously every 6 hours will be administered during the first 24 hours, followed by paracetamol 1 g orally every 8 hours after oral intake is established. Tramadol hydrochloride 100 mg intravenously every 12 hours will also be administered unless clinically contraindicated. Nonsteroidal anti-inflammatory drugs are not mandatory components of the protocol and may be used only when clinically appropriate. If the Numeric Rating Scale pain score is 4 or higher at rest or with coughing or movement, intravenous morphine 2 mg will be administered as rescue analgesia, with further analgesic treatment provided according to clinical need. | Other | Standard Multimodal Systemic Analgesia, Standard Multimodal Systemic Analgesia + Bilateral PIFB |
Primary outcome
Incidence of Clinically Significant Chronic Poststernotomy Pain
Time frame: Postoperative Day 90
The proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90 will be assessed. Clinically significant chronic poststernotomy pain will be defined as pain that develops after surgery or is aggravated by surgery; is localized to the sternotomy line, parasternal region, chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection; persists or recurs at 3 months after surgery; and has an average intensity of at least 3 on the 0-10 Numeric Rating Scale (NRS) during the preceding 7 days. Pain better explained by sternal wound infection, mediastinitis, sternal instability or nonunion, recurrent myocardial ischemia, malignancy, or another clinical condition will not be classified as chronic poststernotomy pain. The outcome will be assessed by an outcome assessor blinded to treatment allocation. Higher incidence indicates a less favorable outcome.
31 secondary outcomes
Postoperative Pain Intensity at Rest
Time frame: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Postoperative Pain Intensity During Coughing or Deep Breathing
Time frame: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Postoperative Pain Intensity During Mobilization
Time frame: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Intraoperative Opioid Consumption
Time frame: Intraoperative period
Requirement for Rescue Analgesia
Time frame: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Number of Rescue Analgesic Administrations
Time frame: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Time to First Rescue Analgesia
Time frame: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Incidence of Postoperative Nausea
Time frame: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Incidence of Postoperative Oversedation
Time frame: From the end of surgery through 5 days after surgery or hospital discharge, whichever occurs first
Incidence of Respiratory Depression
Time frame: From the end of surgery through 5 days after surgery or hospital discharge, whichever occurs first
Time to Tracheal Extubation
Time frame: Up to postoperative day 90
Duration of Invasive Mechanical Ventilation
Time frame: Up to postoperative day 90
Intensive Care Unit Length of Stay
Time frame: Up to postoperative day 90
Hospital Length of Stay
Time frame: Up to postoperative day 90
Incidence of Persistent Postoperative Pain
Time frame: Postoperative Day 30
Presence of Any Chronic Poststernotomy Pain
Time frame: Postoperative Day 90
Average Chronic Poststernotomy Pain Intensity
Time frame: Postoperative Day 90
Worst Chronic Poststernotomy Pain Intensity
Time frame: Postoperative Day 90
Neuropathic Pain Features Assessed With the Douleur Neuropathique en 4 Questions (DN4)
Time frame: Postoperative Day 90
Neuropathic Pain Features Assessed With the Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Time frame: Postoperative Day 90
Cumulative Postoperative Opioid Consumption Through 24 Hours
Time frame: From the end of surgery through 24 hours after surgery
Cumulative Postoperative Opioid Consumption Through 48 Hours
Time frame: From the end of surgery through 48 hours after surgery
Cumulative Postoperative Opioid Consumption Through 120 Hours
Time frame: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Incidence of Postoperative Vomiting
Time frame: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Average Persistent Postoperative Pain Intensity
Time frame: Postoperative Day 30
Worst Persistent Postoperative Pain Intensity
Time frame: Postoperative Day 30
Ongoing Analgesic Use for Persistent Postoperative Pain
Time frame: Postoperative Day 30
Ongoing Analgesic Use for Chronic Poststernotomy Pain
Time frame: Postoperative Day 90
Pain-Related Sleep DisturbanceDescription:
Time frame: Postoperative Day 90
Pain-Related Physical Activity Limitation
Time frame: Postoperative Day 90
Pain-Related Impairment of Activities of Daily Living
Time frame: Postoperative Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data collected in this study will not be made available to researchers outside the primary study team. No external individual participant data sharing is planned because the study protocol and informed consent do not include a prospective data-sharing arrangement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecto-Intercostal Fascial Plane Block and Standardized Multimodal Systemic Analgesia in people with Chronic Poststernotomy Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senem Girgin, M.D. (+90 505 836 97 12, senemcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Significant Chronic Poststernotomy Pain (time frame: Postoperative Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.